At the request of the parties, U.S. Magistrate Judge Roy S. Payne of the U.S. District Court for the Eastern District of Texas dismissed the case Aug. 1. In May, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s preliminary injunction barring Aurobindo from continuing to sell its competing isosulfan blue product, a dye used to map lymph nodes, finding the product infringed patents licensed to Mylan and undercut Mylan’s sales of its own isosulfan blue product.

The settlement details are confidential, so it’s unclear whether the deal they struck will enable Aurobindo to reenter the market at some point before the patents expire. For now, Mylan remains the sole seller of isosulfan blue products.

Isosulfan Blue Market

Annual sales for isosulfan blue are between $50 million and $57 million, and isosulfan blue is a $35 million product for Mylan, according to Bloomberg Intelligence analyst Elizabeth Krutoholow.

Before the appeals court barred Aurobindo from selling its product, Mylan and Aurobindo were essentially the only major competitors in the U.S. isosulfan blue market, Krutoholow said.

Tyco Healthcare Group LP and Novation LLC had products on the market, but both have fallen off, Krutoholow told Bloomberg BNA.

Patent Challenge Dropped

Apicore US LLC licenses the isosulfan blue patents to Mylan. The patents at issue in the litigation include U.S. Patent Nos. 9,353,050 (the ‘050 patent), 7,662,992 and8,969,616.

In addition to terminating litigation with Mylan in district court over the patents, Aurobindo subsidiary Auromedics Pharma LLC also agreed to end a challenge to the ‘050 patent it filed before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board in January. The ‘050 patent claims a process for preparing isosulfan blue.